Study of MiniMed* 640G Insulin Pump with SmartGuard* in prevention of Low Glucose Events in adults with Type 1 diabetes (CEP311)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Age 24-75 years old at time of screening.
2. Diagnosed with Type 1 diabetes *10 years prior to screening.
3. On CSII therapy for * 6 months prior to screening.
4. Not on Real Time Continuous Glucose Monitoring for * 3 months prior to screening.
5. HbA1c value *5.8% and *10.0% as assessed by local lab * 15 days prior to screening or performed at screening.
6. A documented Severe Hypoglycemia event * 12 months prior to screening, OR Clarke score *4 assessed at time of screening, OR Gold score *4 assessed at time of screening.
7. Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.

Exclusion Criteria

1. Untreated Addison*s disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
2. Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
3. Renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test * 3 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations.
4. Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
5. Current pregnancy or intention to conceive.
6. Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
7. Alcohol or drug abuse, other than nicotine, per investigator judgment.
8. Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
9. Legally incompetent, illiterate or vulnerable person.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Mean number of sensor glucose hypoglycaemic events below or equal to 55 mg/dL<br /><br>(3.0 mmol/L) per patient/week. The mean number of sensor glucose hypoglycaemic<br /><br>events will be calculated in each study arm and a between group comparison will<br /><br>be performed. Sensor glucose data for the primary endpoint will consist of 6<br /><br>weeks of sensor readings in both arms in the randomization phase (as<br /><br>illustrated in Figure 1 (2 weeks (Visit 10 to 11) + 2 weeks (Visit 12 to 13) +<br /><br>2 weeks (Visit 14 to 15)).<br /><br><br /><br>A hypoglycemic event is defined as sensor glucose values of 55 mg/dL (3.0<br /><br>mmol/L) or less for more than 20 consecutive minutes. When the time between two<br /><br>successive events is less than 30 minutes, they will be combined and counted as<br /><br>one event. </p><br>

Secondary Outcome Measures